DILATOR

GUDID 00888118055217

KLS-Martin L.P.

Urethral bougie, reusable
Primary Device ID00888118055217
NIH Device Record Key655fbb55-ee46-43e4-8406-d2e3811aa014
Commercial Distribution StatusIn Commercial Distribution
Brand NameDILATOR
Version Model Number31-599-20-07
Company DUNS826499238
Company NameKLS-Martin L.P.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(904)641-7746
EmailKLS-UDI-Info@klsmartin.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100888118055217 [Primary]

FDA Product Code

FBXSOUND, URETHRAL, METAL OR PLASTIC

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00888118055217]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-08-22
Device Publish Date2018-09-26

On-Brand Devices [DILATOR]

1088811800203400-101-17-07
1088811800202700-101-16-07
0088811812098448-265-55-14
0088811805593435-180-03-07
0088811805592735-180-02-07
0088811805591035-180-01-07
0088811807145348-265-55-07
0088811806899643-611-02-07
0088811806898943-611-01-07
0088811806897243-610-02-07
0088811806896543-610-01-07
0088811805537832-460-14-01
0088811805536132-460-12-01
0088811805535432-430-26-01
0088811805534732-430-24-01
0088811805533032-430-22-01
0088811805532332-430-20-01
0088811805531632-430-18-01
0088811805530932-430-16-01
0088811805529332-430-14-01
0088811805528632-430-12-01
0088811805527932-430-10-01
0088811805526232-430-08-01
0088811805525532-430-06-01
0088811805524832-430-04-01
0088811805523132-430-02-01
0088811805521731-599-20-07
0088811805520031-599-18-07
0088811805458627-115-14-07
0088811805457927-113-14-07

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